Roche’s Genentech has sued Amgen for not giving up the info Genentech experts need to mount a patent infringement attack on Amgen’s biosimilar for Avastin, its…

President Trump told Robert Kennedy Jr. he won't "back down" from plans to create vax safety commission, despite guaranteed "uproar"…

It is not as if Israeli drugmaker Teva didn’t already have enough on its plate, what with its CEO having been shown the door, a court overturning patents to…

Charles River Laboratories has unloaded QS Pharma, a Philadelphia-area CDMO, months after picking it up as part of its $585 million buyout of WIL Research.

The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying…

The FDA has again slammed a Japanese drug company in a warning letter, this time for not doing enough to prevent contamination during aseptic filling.

At the Conference on Retroviruses and Opportunistic Infections (CROI), GSK and Gilead present data on drug regimens that could be dueling blockbusters.

Sun Pharma says it could be a few more quarters before it resolves FDA concerns over its key plant in Halol, a situation that continues to be a drag on its…

India’s Aurobindo has acquired four biosimilar products from a Swiss company and says it is building a manufacturing plant to support the production of those…

Manufacturing